Alphanate
NDC 68516-4613
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.
Alphanate is a BLA-approved product labeled by Grifols Usa, Llc. This product contains human factor VIII (also called antihemophilic factor) and von Willebrand factor complex. It is supplied as a product. This product entry covers the primary NDC 68516-4613 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
68516-4613
Proprietary Name:
Alphanate
Product Type: [3]
Code Navigator:
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
68516
Product Label ID:
FDA Application Number: [6]
BLA102475
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.
Marketing Timeline
Start Marketing Date: [9]
08-15-1978
End Marketing Date: [10]
02-29-2024
Listing Expiration Date: [11]
02-29-2024
Exclude Flag: [12]
D
Code Structure Chart
Product Details
What is NDC 68516-4613?
The NDC code 68516-4613 is assigned by the FDA to the product Alphanate. This pharmaceutical product is labeled by Grifols Usa, Llc and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 68516-4613-2. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
This product contains human factor VIII (also called antihemophilic factor) and von Willebrand factor complex. Factors are proteins normally found in the blood that help the blood to thicken (clot) and stop any bleeding. People with low levels of factor VIII and von Willebrand factor are at risk for bleeding longer after an injury/surgery and for bleeding inside the body (especially into the joints and muscles). This product is used to temporarily replace the missing factors and reduce bleeding. Different brands of this product have different amounts of these factors, and therefore different uses. These products are not interchangeable. Do not change brands of this medication without the approval of your doctor. Some products are used to control and prevent bleeding episodes in people with low levels of factor VIII (hemophilia A). Some products are used to treat bleeding episodes in people with low levels of von Willebrand factor (von Willebrand disease) who do not respond to or cannot tolerate desmopressin. Some products are used to prevent excessive bleeding during and after surgery in patients with von Willebrand disease.
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- HUMAN COAGULATION FACTOR VIII/VON WILLEBRAND FACTOR COMPLEX (UNII: 5T6B772R4Q)
- HUMAN COAGULATION FACTOR VIII/VON WILLEBRAND FACTOR COMPLEX (UNII: 5T6B772R4Q) (Active Moiety)
Which are the Inactive Ingredients associated UNII Codes?
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:
- ALBUMIN HUMAN (UNII: ZIF514RVZR)
- ARGININE (UNII: 94ZLA3W45F)
- HISTIDINE (UNII: 4QD397987E)
- WATER (UNII: 059QF0KO0R)
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Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the End Marketing Date? This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
